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MedinCell H1 25/26 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.H1 25/26 earnings summary9 Dec, 2025
Executive summary
Total income for the half-year reached €14.1 million, up 50% year-over-year, driven by strong UZEDY® royalty growth, R&D partnerships, and new development contracts, including with AbbVie and the Gates Foundation.
UZEDY® delivered robust sales growth, received FDA approval for Bipolar I Disorder, and launched in South Korea and Canada.
Olanzapine LAI NDA was submitted to the FDA, with potential approval and US launch expected in late 2026, and positive Phase 3 safety data with no PDSS events.
The pipeline advanced with late-stage and global health programs, including Gates Foundation and iM4TB collaborations targeting pain, contraception, malaria, and tuberculosis.
Strengthened governance with new board appointments and performance-based share grants.
Financial highlights
Revenue for the half-year ended September 30, 2025, increased by 50% year-over-year to €14.1 million, with UZEDY® royalties up 50% in euro and 65% in USD, reaching €4.2 million.
Operating expenses rose 22% year-over-year, mainly due to R&D, with 64% of costs allocated to R&D, mostly partner-funded.
Operating loss improved by 13% to €6.6 million; net loss widened to €16.1 million, mainly due to a €6.8 million non-cash adjustment from EIB warrants and higher financial charges.
Cash and equivalents stood at €53.5 million at September-end, providing at least 12 months of liquidity.
Gross financial debt was €71.1 million; net financial debt at €17.6 million.
Outlook and guidance
UZEDY® 2025 sales guidance confirmed at $190–200 million, with Q4 outlook of $55–65 million.
Olanzapine LAI FDA review expected to conclude in Q4 2026, with European submission to follow and commercial launch anticipated before year-end 2026.
AbbVie #1 program set to enter clinical development in 2026, with up to $315 million in milestones and low double-digit royalties.
Return to profitability targeted for fiscal 2026–2027, though a weak USD could delay this.
Sufficient liquidity to meet all financial commitments for at least the next 12 months.
Olanzapine LAI's competitive edge?
EIB warrant revaluation impact on financials?
AbbVie partnership: next clinical steps?
How does MedinCell's Olanzapine LAI overcome prior market hurdles?
Impact of UZEDY's Bipolar I approval and int'l expansion
MedinCell's strategy to maintain tech leadership
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H2 25/2616 Jun, 2026
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Frequently asked questions
MedinCell S.A. is a pharmaceutical company specializing in the development of long-acting injectable therapies using its proprietary BEPO technology. This technology allows for the sustained release of active pharmaceutical ingredients over several days, weeks, or months from a single, bioresorbable injection. The company's portfolio includes products targeting various therapeutic areas, with a focus on treating conditions such as schizophrenia and post-surgical pain. MedinCell collaborates with global pharmaceutical companies and organizations to advance its product pipeline. The company is headquartered in Jacou, France, and its shares are listed on the Euronext Paris.
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